Af­ter clear­ing an FDA hur­dle, Am­gen wins an FDA OK on CKD drug Parsabiv

Am­gen bare­ly man­aged to com­plete a full para­graph when the phar­ma gi­ant an­nounced last Au­gust that the FDA had re­ject­ed Parsabiv (etel­cal­ce­tide) for sec­ondary hy­per­parathy­roidism (SH­PT), a dis­ease that af­fects chron­ic kid­ney dis­ease pa­tients on he­modi­a­lyis. But the com­pa­ny man­aged to whip up some­thing more in-depth when it an­nounced last night that the agency had hand­ed over an ap­proval.

Reg­u­lar­ly hailed as a top late-stage drug at Am­gen $AMGN, in­ves­ti­ga­tors test­ed the drug in more than a thou­sand pa­tients, re­port­ed­ly meet­ing its pri­ma­ry end­points by slash­ing dan­ger­ous­ly high parathy­roid hor­mone lev­els. In one study 74.7% of sub­jects on the drug hit its tar­get, com­pared to just 8.9% in the place­bo arm. In an­oth­er Phase III tri­al the new drug out­per­formed Am­gen’s block­buster drug Sen­si­par, which earned $1.4 bil­lion.

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